Templates

The Office of Regulatory Support (ORS) can provide templates for many of the FDA submissions during the lifetime of an Investigational New Drug (IND) or Investigational Device Exemption (IDE).

Contact the Research Help Desk if you need assistance with drafting communications to the FDA or for templates for any of the following items:

Investigational New Drug (IND) Applications

Request for IND Exemption

Pre-IND meeting request and briefing package

IND Application

IND Annual Report

IND Withdrawal

IND Letter of Cross-Reference/Letter of Authorization

Cover Letters

Investigator Brochures

Investigational Device Exemptions (IDE) Applications

Cover Letter

Pre-Submission meeting request and briefing package

IDE Application

IDE Progress Report

Final Reports

In addition to these templaces specific to submitting the IND and IDE applications to the FDA, there are many templates that are central to conducting clinical research, including for informed consent and several types of study protocols which can be found at the OHSP RSRB webpage.